Content - Certificates

Certificates

Phonak’s devices are regulated by government agencies, healthcare authorities, and other regulatory bodies worldwide. These organizations verify that throughout the life cycle of our products we are fulfilling the requirements of applicable health and safety regulations. We are committed to maintaining transparent, constructive, and professional relationships with all applicable regulatory authorities on policy, product submissions, compliance, and product performance. Find here the full text of the EU Declaration of Conformity.

 

Declaration of Conformity
Roger Covert C (pdf)
Roger Covert Dual C (pdf) 
Roger Covert RCU C (pdf)
Roger Earpiece C (pdf)
Profilo NANO AC DM (pdf)
Roger BaseStation (pdf)
Roger Earpiece (pdf)
Roger Repeater (pdf)
Roger Touchscreen Mic (pdf)
Invisity (pdf)
CE-Certificates 
Serenity Classic (pdf)
Serenity SP (pdf)
Serenity SPC range (pdf)
Serenity DP (pdf)
Serenity DPC range  (pdf)
Primero DPC (pdf)
FreeCom (pdf)
Dominator (pdf)
ComCom (pdf)
Silemo mini (pdf)

 

Statement for the new PPE regulation: 
On the 21 April 2018 the PPE Directive 89/686/EEC was repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. 

Article 47 of the new Regulation 2016/425 foresees a specific transitional period of 1 year (21 April 2018 to 20 April 2019) where both, the old Directive and the new Regulation, are applicable. According to Article 47 (1), products which have been placed on the market before 21 April 2019 in compliance with the old Directive can continue to be made available on the market even after 21 April 2019.

Furthermore, Article 47 (2) lays down that EC type-examination certificates and approval decisions issued under the old Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date. All PPE products from Phonak Communications AG were placed on the market with EC type-examination and have valid EC type-examination certificates for conformity with the PPE Directive 89/686/EEC without expiration date before 21 April 2023. Our team is working on a re-certification schedule for obtaining EC type-examination certificates for compliance with the new Regulation 2016/425 in due time.